On 5 June, InflaRx announced top-line Phase IIb results for IFX-1 in hidradenitis suppurativa (HS). However, IFX-1 did not demonstrate a statistically significant dose-dependent effect on the Hidradenitis Suppurativa Clinical Response (HiSCR) rate at 16 weeks post-treatment. This result has failed to prove the high efficacy of InflaRx’s first-in-class monoclonal drug and could restrict the company’s ability to capture a greater patient share in the HS market if approved.

Hidradenitis suppurativa treatment

IFX-1 is a monoclonal anti-human complement factor C5a antibody, which blocks the activity of C5a. Therefore, IFX-1 inhibits the formation of a membrane attack complex. This then blocks the amplification of inflammatory responses. IFX-1 has been developed by InflaRx and has undergone three Phase II clinical trials in HS patients. In these studies, IFX-1 was found to be well tolerated in HS patients.

Top-line results were presented from the SHINE Phase IIb study. The randomised, double-blind, placebo-controlled study was conducted with a total of 179 patients in four active dose arms and a placebo control arm, with over 40 sites in nine countries in North America and Europe. The primary endpoint of the study was a dose-response signal, which was assessed by the HiSCR. The primary statistical analysis by multiple-comparison modelling showed no significant dose responses for the IFX-1 treatment. At the minimal dose (400mg every four weeks), low dose (800mg every four weeks), medium dose (800mg every two weeks), and high dose (1200mg every two weeks), the HiSCR was 40.0%, 51.5%, 38.7%, and 45.5%, respectively. Comparatively, patients in the placebo-controlled arm had a HiSCR of 47.1%. Overall, IFX-1 did not demonstrate a statistically significant dose-dependent effect in HS patients.

Currently, the only approved biologic on the HS market is Abbvie’s Humira (adalimumab), which has been approved for use in HS patients since 2018. Since there is only one biologic on the HS market, there is much room for a new biologic to be approved. Furthermore, there is a strong unmet need for biologics with strong efficacy to be approved in the HS market. As Humira is the only biologic currently available on the market, GlobalData anticipates that more biologics will be approved in the coming years that could directly compete with Humira, thus affecting its market share.

However, to be a strong contender in the HS market, strong efficacy and safety will be required in order to capture the majority share of patients.

Upcoming report
GlobalData (2019). Hidradenitis Suppurativa – Opportunity Analysis and Forecasts to 2028, to be published